Handbook of Pharmaceutical Granulation Technology -

Handbook of Pharmaceutical Granulation Technology

Dilip M. Parikh (Herausgeber)

Buch | Hardcover
656 Seiten
2009 | 3rd New edition
Crc Press Inc (Verlag)
978-1-4398-0789-7 (ISBN)
219,95 inkl. MwSt
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The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the reader in selecting the ideal technology for his/her company’s particular drug delivery system. This knowledge helps ensure that regulatory guidelines are followed and met in a cost-effective manner.



Here are just a few of the new topics discussed in this revised and expanded handbook:











spray drying
nanotechnology
biotechnologically derived drugs
nutraceuticals
controlled release drugs
particle engineering
supercritical fluids
concepts of design space
process optimization
regulation harmonization by global health authorities
process controlexpert systems
Process Analytical Technology (PAT)
regulatory issues in granulation








In addition, all chapters in the Handbook of Pharmaceutical Granulation Technology explore the fundamentals of powder characterization, granulation, and state-of-the-art technologies, modeling, application of expert systems, and manufacturing optimization.

Preface
Contributors
Introduction, Dilip M. Parikh
Theory of Granulation: An Engineering Perspective, Bryan J. Ennis

PARTICLE FORMATION
Drug Substance and Excipient Characterization, Lai Wah Chan, Xiang Kou, and Paul W. S. Heng
Binders in Pharmaceutical Granulation, Thomas Dürig
Spray Drying and Pharmaceutical Applications, Metin Çelik and Susan C. Wendell
Supercritical Fluid Technology, Martin A. Wahl
Pharmaceutical Applications of Nanoengineering, Deepak Thassu, Yashwant Pathak, and Michel Deleers

GRANULATION PROCESSES
Roller Compaction Technology, Ronald W. Miller
Wet Granulation in Low- and High-Shear Mixers, Rajeev Gokhale and Namrata R. Trivedi
Batch Fluid Bed Granulation, Dilip M. Parikh and David M. Jones
Single-Pot Processing, Harald Stahl and Griet Van Vaerenbergh
Extrusion-Spheronization as a Granulation Technique, David F. Erkoboni
Continuous Granulation, Chris Vervaet and Jean Paul Remon

PRODUCT ORIENTED GRANULATIONS
Effervescent Granulation, Guia Bertuzzi
Granulation Approaches in Biotech Industry, Tuo Jin, Weien Yuan, and Hui Li
Granulation of Plant Products and Nutraceuticals, Dilip M. Parikh
Granulation Approaches for Modified Release Products, Neelima Phadnis and Sree Nadkarni
Granulation of Poorly Water-Soluble Drugs, Albert W. Brzeczko, Firas El Saleh, and Jiao Yang
Granulation Approaches for Orally Disintegrating Formulations, Gopi Venkatesh
Melt Granulation, Chris Vervaet and Jean Paul Remon

CHARACTERIZATION AND SCALE-UP
Sizing of Granulation, Gurvinder Singh Rekhi and Richard Sidwell
Granulation Characterization, Cecil W. Propst
Bioavailability and Granule Properties, Sunil S. Jambhekar
Granulation Process Modeling, Ian T. Cameron and Fu Y. Wang
Scale-Up Considerations in Granulation, Yinghe He, Lian X. Liu, James D. Litster, and Defne Kayrak-Talay
Advances in Process Controls and End-Point Determination, Kevin A. Macias and M. Teresa Carvajal

OPTIMIZATION STRATEGIES, TOOLS AND REGULATORY CONSIDERATIONS
Expert Systems and Their Use in Pharmaceutical Applications, Metin Çelik and Susan C. Wendell
Regulatory Issues in Granulation: The Pharmaceutical Quality for the 21st Century—A Risk-Based Approach, Prasad Kanneganti
Quality by Design and Process Analytical Technology in Granulation, Gopi Vudathala, Stanley Rodgers, and John E. Simmons
Index

Erscheint lt. Verlag 24.11.2009
Reihe/Serie Drugs and the Pharmaceutical Sciences ; 4
Zusatzinfo 100 Halftones, black and white; 200 Tables, black and white; 300 Illustrations, black and white
Sprache englisch
Maße 178 x 254 mm
Gewicht 1960 g
Themenwelt Medizin / Pharmazie Medizinische Fachgebiete Dermatologie
Medizin / Pharmazie Medizinische Fachgebiete Pharmakologie / Pharmakotherapie
Medizin / Pharmazie Pflege
Medizin / Pharmazie Pharmazie
Technik
ISBN-10 1-4398-0789-2 / 1439807892
ISBN-13 978-1-4398-0789-7 / 9781439807897
Zustand Neuware
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